Targeting Body Image Among Women of Higher Body Weight

NCT ID: NCT04810247

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-04
• Study Completion Date: 2022-05-19

Brief Summary

The goal of this study is to modify the evidence-based Body Project intervention to more powerfully target weight and shape concern among women with BMI between 25-40 using exploratory sequential mixed methodology (using both quantitative and focus group data). Initial modifications to the intervention will be made to incorporate content targeting weight stigma and to ensure the materials are developmentally appropriate for adult women. Then a small group (n=5-10) of women with high weight and shape concern will receive the 4 week body project intervention; we will collect pre-post questionnaire data on weight and shape concern, thin ideal and weight stigma, and use ecological momentary assessment to examine in-the-moment thoughts about weight and shape. The body project intervention will then be revised using this information in combination with participant feedback elicited during a focus group session. The next iteration of the intervention will then be tested in another small group of n=5-10; it is estimated that it will take 4-6 iterations to achieve a more robust intervention program that is acceptable to the target sample. Subgroups (race/ethnicity, BMI class) will be evaluated to ensure suitability across groups.

Detailed Description

Women with overweight or obesity, over the age of 25, who report high weight and shape concern and a desire to lose weight will be recruited from the community. Participants will be recruited and enrolled in cohorts of 5-10 individuals, with a focus on ensuring that each group has approximately 50% women of color (i.e., identify as non-white).

Participants will attend, with all individuals in their cohort, the four weekly body project intervention sessions led by a trained facilitator. Each session is approximately 60 minutes long and relies on guided discussion and group activities to engage participants. In between group meetings, participants will be given exercises to complete prior to the next session. The intervention content will be modified prior to the first cohort in order to identify factors relevant for body image among women who would medically benefit from weight loss (e.g., internalized weight bias). The active ingredients will remain the same while modifying content and assignments or exercises to enhance effects among the target population.

Participants will complete a baseline assessment of self-report surveys and a 7-day ecological momentary assessment period. All assessment procedures must be complete prior to the first group meeting. After the fourth and final group meeting, participants will complete a second assessment including self-report surveys and a 7-day EMA period. The data collected from the pre and post-assessments will be used to shape the focus group script. Within four weeks of the last group meeting, participants will attend a focus group meeting led by a facilitator who was not involved in intervention delivery to better understand the participant experience with the intervention content. Key changes may include expanding content to address contextual factors that cause negative weight/shape-related thoughts among women with overweight or obesity and to target weight stigma (internalized), modifying exercises that were reviewed negatively, and incorporating explicit discussion of weight management.

Following the focus group, the intervention will be revised using the quantitative and qualitative data collected from each cohort. The process will be repeated to refine the intervention through iterative testing with small groups of individuals (n≤10). It is anticipated that approximately 4-6 groups will be required. Upon completion of all study procedures, participants will receive information and resources for healthy weight loss.

Conditions

Obesity; Overweight; Body Image

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Body Project intervention

Group Type: EXPERIMENTAL

Body Project

Intervention Type: BEHAVIORAL

The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised for use among adult women with weight/shape concern and higher body weight.

Interventions

Body Project

The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised for use among adult women with weight/shape concern and higher body weight.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Female
• BMI between 25-40
• EDE-Q weight concern subscale>4
• EDE-Q shape concern subscale>4.25
• Personal use of cell phone
• Able to engage in moderate intensity activity
• Desire for weight loss

Exclusion Criteria

• No eating disorder history
• Not pregnant
• Not breastfeeding
• No delivery within 9 months
• No substance abuse disorder
• No weight loss medication or history of bariatric surgery
• No other weight loss program participation

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kayloni Olson

Assistant Professor (Research)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Weight Control and Diabetes Research Center

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

K23DK124578

Identifier Type: NIH

Identifier Source: org_study_id

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